CancerPhase 3COV-IMMUNONCT04442048
Immunization With IMM-101 vs Observation for Prevention of Respiratory and Severe COVID-19 Related Infections in Cancer Patients at Increased Risk of Exposure
A Phase 3 study testing IMM-101 and Observation in people with Cancer and Covid-19, run by Canadian Cancer Trials Group at 8 sites in Canada.
Trial summary
The purpose of this study is to find out if immunization with IMM-101 will reduce the incidence of severe respiratory and COVID-19 infections in cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- IMM-101 and Observation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 195 participants
- Where
- 8 sitesCanada
- Study dates
- 1 Oct 2020to 22 Dec 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient must be undergoing (or be planned to undergo) active treatment for one or more solid malignancy, lymphoma or myeloma. active treatment includes adjuvant, neoadjuvant and palliative intent treatment with surgery, radiation, chemotherapy, targeted therapy or immunotherapy.
- Patients must have one or more of the following risk factors [CDC 2019] for a severe COVID-19 infection:
- Age > 65 years old
- Hypertension (on medications);
- Type 1 or 2 Diabetes (on medication)
- A relevant chronic condition as per the investigator based on the medical record, including:
Show all 23Show fewer
- heart (e.g. heart failure, coronary artery disease, congenital heart disease, cardiomyopathies, and pulmonary hypertension)
- lung (e.g. chronic obstructive pulmonary disease (COPD including emphysema and chronic bronchitis), moderate to severe asthma, idiopathic pulmonary fibrosis and cystic fibrosis)
- liver cirrhosis
- serious kidney disease requiring dialysis
- Receiving systemic therapy (such as cytotoxic chemotherapy, immunotherapy or targeted agents excluding single-agent hormonal therapy)
- Body Mass Index > 40
- Living in a nursing home or long term care facility
- Patient must have a life expectancy of >6 months as assessed by the investigator
- Patient must have an ECOG Performance Status ≤ 2
- Patient has adequate organ function appropriate for the therapy the patient is planned to receive in the opinion of the investigator and based on local assessment and practices.
- Patient is aged ≥ 18 years
- Patient has agreed to receive pneumococcal vaccination and a seasonal influenza vaccination in accordance with Canadian Guidelines.
- Patient is able (i.e. sufficiently fluent) and willing to complete the health utility questionnaires in either English or French.
- Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate.
- Patient must be willing to provide identifying information including provincial health insurance number to facilitate data linkage and follow up.
- Patients must be accessible for treatment and follow-up. Investigators must assure themselves the patients enrolled on this trial will be available for complete documentation of the treatment, adverse events, and follow-up.
- Women/men of childbearing potential must have agreed to use a highly effective contraceptive method throughout the treatment period and for at least 3 months after discontinuation of treatment.
Who cannot join
- Patient previously received treatment with IMM-101.
- Patient cannot have either at present or in the past, a positive test for COVID-19 infection. If a patient has been tested for COVID-19, result must be confirmed as negative prior to enrollment.
- Patient cannot have experienced "flu-like symptoms" within 14 days prior to enrollment, including fever, extreme fatigue, new or worsening cough, myalgias, new or worsening dyspnea, and/or sputum production.
- Patient is receiving concomitant treatment with another investigational product or has received such treatment within the 3 weeks prior to enrollment.
- Patient has any co-existing active infection that, in the opinion of the Investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate.
- Patient has previously experienced an allergic reaction to any mycobacterial product, including the BCG vaccine.
Show all 12Show fewer
- Patients with superficial bladder cancer or any other condition currently receiving or planned to be treated with BCG.
- Patient has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies) or a known history of or is known to have a positive test for Hepatitis B (HBsAg reactive) or Hepatitis C (HCV RNA [qualitative]).
- Patients with prior or concurrent leukemia.
- Patient has had a prior bone marrow transplant.
- Patient is pregnant or breast-feeding
- Patient has documented history of clinically severe autoimmune disease or a syndrome that requires systemic steroids or immunosuppressive agents. This includes patient requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent, or depot corticosteroids in the 6 weeks before enrollment) or immunosuppressant drugs (such as azathioprine, tacrolimus, cyclosporine, etc.) within the 14 days prior to enrollment. Inhaled or topical steroids, and adrenal replacement steroid doses ≤ 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease. Steroids used for premedication prior to chemotherapy or as part of a chemotherapy regimen are allowed.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Canada8 sites
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, L8V 5C2
London Regional Cancer Program
London, Ontario, N6A 5W9
CHUM-Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2X 3E4
The Research Institute of the McGill University
Montreal, Quebec, H4A 3J1
Ottawa Hospital Research Institute
Ottawa, Ontario, K1H 8L6
CIUSSS de l'Estrie - Centre hospitalier
Sherbrooke, Quebec, J1H 5N4
Odette Cancer Centre
Toronto, Ontario, M4N 3M5
University Health Network
Toronto, Ontario, M5G 2M9
About this study
Official title: COV-IMMUNO: A Randomized, Phase III Trial of Immunization With IMM-101 Versus Observation for the Prevention of Severe Respiratory and COVID-19 Related Infections in Cancer Patients at Increased Risk of Exposure
The purpose of this study is to find out if immunization with IMM-101 will reduce the incidence of severe respiratory and COVID-19 infections in cancer patients.
Read the detailed description
IMM-101 is a new type of immune stimulating therapy being developed for the treatment of cancer that may also help in preventing severe respiratory and COVID-19 infections. Laboratory tests show that IMM-101 works by activating parts of the immune system that are also involved with protecting against viral and bacterial infections, so that if you are exposed to these types of infections your body may be able fight off the infection better. That could help prevent severe symptoms from respiratory and COVID-19 related infections. It has been studied in over 300 cancer patients who have also been receiving other cancer treatments, including chemotherapy and radiation, and seems promising, but it is not clear if it can offer better results than not having the immunization at all.
- Being tested
- IMM-101, Observation
- Medical subject headings
- Neoplasms, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMM-101Biological
Three doses of IMM-101 on days 0, 14, and 45.
ObservationOther
No active treatment. Observation only
| Study group | Role | What they receive |
|---|---|---|
| IMM-101 | Experimental | The treatment regimen with IMM-101 will be one 1.0 mg (= 0.1 mL) dose given on Day 0, followed by a second dose of 0.5 mg (= 0.05 mL) on Day 14 (-2/+5 days), and a third Dose of 0.5 mg (= 0.05 mL) on Day 45 (+/-14 days) Receives: Biological: IMM-101 |
| Observation | Active comparator | Not described Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of "flu-like illness" which includes:
- WHO definition of "influenza-like illness" (ILI) [Fitzner 2018] or confirmed viral/bacterial respiratory infection AND
- Results in a change or delay in cancer treatment or requirement for and unscheduled medical assesment, hospitalization or death.
Measured: 1 year
Secondary outcomes (10)
The incidence of documented COVID-19 infection (confirmed by any Health Canada approved COVID-19 test. Both symptomatic and asymptomatic infections will be documented
Measured: 1 year
The rate of severe respiratory and COVID-19 infection defined as a confirmed COVID-19 infection leading to hospitalization, ICU admission or death
Measured: 1 year
The number of events that meet the definition of the primary endpoint, as measured within the one-year follow-up (patients may meet the primary endpoint more than once and be counted multiple times).
Measured: 1 year
The incidence of COVID-19 seroconverted patients between baseline, 3 months, 6 months and 12 months
Measured: 3, 6, and 12 months
The incremental cost-effectiveness ratio (in the unit of CAD$ per life-years gained) measured with EQ-5D-5L
Measured: 1 year
Failure-free survival, as time from enrollment to recurrence or progression declared by the investigator on the basis of objective standard evaluation consistent with the disease site or death
Measured: 1 year
Overall survival (OS), as time from enrollment to death from any cause
Measured: 1 year
Incidence, frequency, and severity of AEs considered possibly, probably or definitely related to receipt of IMM-101
Measured: 1 year
Incidence and frequency of local injection site reactions subsequent to IMM-101 administration
Measured: 1 year
Incidence and duration of ICU admission related to documented COVID-19 infection
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2020
- Study start1 Oct 2020
- Primary completion7 May 2024
- Study completion22 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Canadian Cancer Trials GroupThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- Canadian Cancer Trials Group
- Sponsor type
- Research network
- Collaborators
- Immodulon Therapeutics Ltd, BioCan Rx, Canadian Cancer Society (CCS), ATGen Canada Inc, Canadian Centre for Applied Research in Cancer Control (ARCC), Ontario Institute for Cancer Research
- Responsible party
- Sponsor
- Investigators
- Rebecca A Auer, Study chair, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04442048
- Sponsor's protocol ID
- IC8
- Acronym
- COV-IMMUNO
- Status last verified
- Dec 2025
- First submitted
- 19 Jun 2020
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COV-IMMUNO: A Randomized, Phase III Trial of Immunization With IMM-101 Versus Observation for the Prevention of Severe Respiratory and COVID-19 Related Infections in Cancer Patients at Increased Risk of Exposure
- ClinicalTrials.gov ID
- NCT04442048
- Acronym / sponsor ID
- COV-IMMUNO / IC8
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- Canadian Cancer Trials GroupResearch network
- Collaborators
- Immodulon Therapeutics Ltd, BioCan Rx, Canadian Cancer Society (CCS), ATGen Canada Inc, Canadian Centre for Applied Research in Cancer Control (ARCC), Ontario Institute for Cancer Research
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 7 May 2024 (actual)
- Study completion
- 22 Dec 2025 (actual)
- First posted
- 22 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to find out if immunization with IMM-101 will reduce the incidence of severe respiratory and COVID-19 infections in cancer patients.
Detailed description
IMM-101 is a new type of immune stimulating therapy being developed for the treatment of cancer that may also help in preventing severe respiratory and COVID-19 infections. Laboratory tests show that IMM-101 works by activating parts of the immune system that are also involved with protecting against viral and bacterial infections, so that if you are exposed to these types of infections your body may be able fight off the infection better. That could help prevent severe symptoms from respiratory and COVID-19 related infections. It has been studied in over 300 cancer patients who have also been receiving other cancer treatments, including chemotherapy and radiation, and seems promising, but it is not clear if it can offer better results than not having the immunization at all.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IMM-101 | Experimental | Biological: IMM-101The treatment regimen with IMM-101 will be one 1.0 mg (= 0.1 mL) dose given on Day 0, followed by a second dose of 0.5 mg (= 0.05 mL) on Day 14 (-2/+5 days), and a third Dose of 0.5 mg (= 0.05 mL) on Day 45 (+/-14 days) |
| Observation | Active comparator | Other: Observation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Patient must be undergoing (or be planned to undergo) active treatment for one or more solid malignancy, lymphoma or myeloma. active treatment includes adjuvant, neoadjuvant and palliative intent treatment with surgery, radiation, chemotherapy, targeted therapy or immunotherapy.
- Patients must have one or more of the following risk factors [CDC 2019] for a severe COVID-19 infection:
- Patient must have a life expectancy of >6 months as assessed by the investigator
- Patient must have an ECOG Performance Status ≤ 2
- Patient has adequate organ function appropriate for the therapy the patient is planned to receive in the opinion of the investigator and based on local assessment and practices.
Key exclusion criteria (12 listed)
- Patient previously received treatment with IMM-101.
- Patient cannot have either at present or in the past, a positive test for COVID-19 infection. If a patient has been tested for COVID-19, result must be confirmed as negative prior to enrollment.
- Patient cannot have experienced "flu-like symptoms" within 14 days prior to enrollment, including fever, extreme fatigue, new or worsening cough, myalgias, new or worsening dyspnea, and/or sputum production.
- Patient is receiving concomitant treatment with another investigational product or has received such treatment within the 3 weeks prior to enrollment.
- Patient has any co-existing active infection that, in the opinion of the Investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMM-101Three doses of IMM-101 on days 0, 14, and 45. | Biological | IMM-101 |
| ObservationNo active treatment. Observation only | Other | Observation |
Primary outcome
The rate of "flu-like illness" which includes:
Time frame: 1 year
* WHO definition of "influenza-like illness" (ILI) [Fitzner 2018] or confirmed viral/bacterial respiratory infection AND * Results in a change or delay in cancer treatment or requirement for and unscheduled medical assesment, hospitalization or death.
10 secondary outcomes
The incidence of documented COVID-19 infection (confirmed by any Health Canada approved COVID-19 test. Both symptomatic and asymptomatic infections will be documented
Time frame: 1 year
The rate of severe respiratory and COVID-19 infection defined as a confirmed COVID-19 infection leading to hospitalization, ICU admission or death
Time frame: 1 year
The number of events that meet the definition of the primary endpoint, as measured within the one-year follow-up (patients may meet the primary endpoint more than once and be counted multiple times).
Time frame: 1 year
The incidence of COVID-19 seroconverted patients between baseline, 3 months, 6 months and 12 months
Time frame: 3, 6, and 12 months
The incremental cost-effectiveness ratio (in the unit of CAD$ per life-years gained) measured with EQ-5D-5L
Time frame: 1 year
Failure-free survival, as time from enrollment to recurrence or progression declared by the investigator on the basis of objective standard evaluation consistent with the disease site or death
Time frame: 1 year
Overall survival (OS), as time from enrollment to death from any cause
Time frame: 1 year
Incidence, frequency, and severity of AEs considered possibly, probably or definitely related to receipt of IMM-101
Time frame: 1 year
Incidence and frequency of local injection site reactions subsequent to IMM-101 administration
Time frame: 1 year
Incidence and duration of ICU admission related to documented COVID-19 infection
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca A Auer study chair
Ottawa Hospital Research Institute
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing IMM-101 and Observation in people with Cancer and Covid-19, run by Canadian Cancer Trials Group at 8 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of "flu-like illness" which includes: (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2025.